RecruitingPhase 1NCT07133997

Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia

A Phase 1/1b Study Evaluating Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) and Venetoclax in Combination With Blinatumomab in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia


Sponsor

City of Hope Medical Center

Enrollment

26 participants

Start Date

May 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/Ib trial tests the safety and side effects of asparaginase Erwinia chrysanthemi-recombinant-rywn (recombinant Erwinia asparaginase) and venetoclax in combination with blinatumomab and how well the combination works in treating patients with CD19 positive B-cell acute lymphoblastic leukemia (ALL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Asparaginase Erwinia chrysanthemi, a type of protein synthesis inhibitor, is a drug that is made up of the enzyme asparaginase, which comes from the bacterium Erwinia chrysanthemi. It is used in people who cannot take asparaginase that comes from the bacterium E. coli. Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It may also kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a drug used to treat certain types of B-cell acute lymphoblastic leukemia that are CD19 positive (expresses the protein CD19). Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. Blinatumomab is a type of bispecific T-cell engager. Giving asparaginase Erwinia chrysanthemi and venetoclax in combination with blinatumomab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory ALL.


Eligibility

Min Age: 12 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Asparaginase Erwinia chrysanthemi, a procedure called Biospecimen Collection, and others for people with recurrent b acute lymphoblastic leukemia and refractory b acute lymphoblastic leukemia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAsparaginase Erwinia chrysanthemi

Given IM

PROCEDUREBiospecimen Collection

Undergo blood sample collection

BIOLOGICALBlinatumomab

Given CIV

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

DRUGCyclophosphamide

Given cyclophosphamide

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGVenetoclax

Given PO

DRUGVincristine

Given vincristine


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07133997


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